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CGS

123 FDA 510(k) clearances · Product code

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RecordFirmDate
RAICHEM TM CREATINE KINASE REAGENT (K820644)Reagents Applications, Inc.1982-04-01
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (K812593)Harleco1981-10-02
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (K811574)Harleco1981-06-25
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) (K811576)Harleco1981-06-25
CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT (K810853)The Upjohn Co.1981-05-29
CREATINE KINASE REAGENT (K803301)Gilford Diagnostics1981-01-16
COBAS CK-NAC REAGENT (K801299)Roche Analytical Instruments, Inc.1980-07-14
CENTRIFICHEM CK (K800127)Union Carbide Corp.1980-02-13
CHEM-STRATE CK-NAC (K792477)General Diagnostics1979-12-27
REAGENT SYSTEM, NO 46-OV FOR CPK (K781859)Sigma Chemical Co.1978-12-04
CPK REAGENT SET, NAD REDUCTION (K781719)Medical Analysis Systems, Inc.1978-11-03
CPK-L TUBE (K781149)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-08-14
DIAGNOSTIC KIT, CPK (K780311)Sclavo, Inc.1978-04-05
ULTRAZYME PLUS CK-1 (K780100)Harleco1978-03-09
CPK REAGENT SET (K780070)Medical Analysis Systems, Inc.1978-02-13
STAC SYSTEM - ADDITIONAL ANALYTES (K772352)Technicon Instruments Corp.1978-01-31
CLINICARD CK-II (K772258)Harleco1978-01-05
CPK COLOR TEST KIT (K771849)Mallinckrodt Critical Care1977-11-03
CK-1 ULTRAZYME PLUS (K771389)Harleco1977-09-02
MULTISTAT III CPK TEST (K771441)Instrumentation Laboratory CO1977-08-22
CPK ULTRAZYME PLUS (K770694)Harleco Diagnostics1977-07-01
REAGENT CPK, ENZYME (K770319)Icn Pharmaceuticals, Inc.1977-04-05
DYNAZYME-II TM CK-230 KIT (K761344)J.T. Baker Chemical Co.1977-01-05
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